How and When Do I Comply with FDA's Rules to Import Tobacco?

Importers of finished tobacco products may be distributors, tobacco product manufacturers or both. Importers who do not own or operate a domestic establishment engaged in the manufacture, preparation, compounding or processing of a tobacco product are not required to register their establishment or provide product listing. However, they must comply with all other applicable tobacco product manufacturer requirements.

If you do not comply with the requirements, your imported tobacco products are subject to refusal of admission, under section 801 of the FD&C Act.

Reporting through Automated Commercial Environment

Automated Commercial Environment (ACE) is the primary system through which the trade community reports its imports and exports.

For all FDA regulated products, importers are required to submit the following data elements through ACE:

Exporters

You do not need to report to FDA in order to export a tobacco product outside of the U.S. However, tobacco products intended for export may be deemed to be adulterated or misbranded unless the product is:

in accordance with the specifications of the foreign purchaser,

not in conflict with the laws of the country to which it is intended for export,

labeled on the outside of the shipping package that it is intended for export, and

not sold or offered for sale in domestic commerce.

In addition, there are recordkeeping requirements related to exported tobacco products. Notification and recordkeeping requirements for tobacco products exported under Section 801 of the FD&C Act are provided in 21 CFR 101.1.

FDA reports to Congress on the export of tobacco products that do not conform to U.S. tobacco product standards, per the Tobacco Control Act. Currently, there are no documented instances of the export of tobacco products that do not conform to current U.S. tobacco product standards.